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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012836
Company: BOEHRINGER INGELHEIM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERSANTINE DIPYRIDAMOLE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
PERSANTINE DIPYRIDAMOLE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
PERSANTINE DIPYRIDAMOLE 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/06/1961 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2019 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012836s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/012836Orig1s061ltr.pdf
07/29/2015 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.
05/08/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.
08/01/2005 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012836s057ltr.pdf
06/20/2002 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.
02/08/2002 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.
08/05/2004 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12836s054ltr.pdf
05/24/2001 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.
02/08/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.
07/03/1997 SUPPL-51 Labeling

Label is not available on this site.
05/18/1994 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.
02/18/1994 SUPPL-49 Labeling

Label is not available on this site.
03/26/1991 SUPPL-47 Labeling

Label is not available on this site.
02/21/1995 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.
11/08/1988 SUPPL-45 Labeling

Label is not available on this site.
08/30/1989 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.
12/12/1988 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
02/24/1988 SUPPL-41 Labeling

Label is not available on this site.
02/06/1987 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.
12/22/1986 SUPPL-38 Labeling

Label is not available on this site.
10/08/1982 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
12/22/1986 SUPPL-14 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/11/2019 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012836s061lbl.pdf
08/01/2005 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf
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